Friday, April 12, 2013

We are the world (More musings on commercialization of the blood supply)

Updated:13 April 2013

This blog is an update to the two blogs below this one: 'Stop children what's that sound' (Musings on commercialization of our blood supply) and the CSTM's reply to it. The title derives from an American charity recording in 1985 for African famine relief, We are the world. If some readers are growing bored by 3 blogs in a row on the same topic, so be it. To me the history and current developments in Canada's blood system are fascinating in the extreme. The Krever Report into Canada's 'tainted blood scandal' was released in 1997. CBS, which succeeded Canadian Red Cross (with most of the same staff), celebrated its one year anniversary in 1999 and, having been lured to leave a long teaching career to go back into the trenches, I was there as an 'assman'. Actual title was 'assistant lab manager' but the quality dept. addressed all my internal mail as 'assman'. Must admit I loved it!A mere 15 years later, we have the CEO of CBS practically 'pimping' for paid plasma as the way to go. Fascinating stuff, this.Latest development

Health Canada convened a round table of key stakeholders to meet in Toronto 10 Apr. 2013. The meeting was closed to the media. Post-Krever Inquiry, the goal was to create a system that was safe, accountable and fully transparent to consumers and the public. You gotta love the transparency of Canada's blood system today.

Excluding the media reeks of, 'Let's control the message. The media will only confuse the public and get the poor dears upset about nothing.' Father knows best?

SAFETY?

On the matter of blood safety, CBS CEO Graham Sher says there are many safety mechanisms in place today that make plasma products safe, regardless of whether donors are paid.

“It's a very different environment today from 25 or 30 years ago.... If one looks at this purely from the safety point of view, the safety of the finished product that goes into a patient, there is no evidence whatsoever that paying donors result in a less safe product. There is no evidence whatsoever. And there have been numerous studies around the world looking at this.”

Note the repeat of 'no evidence whatsoever'. No doubt that's to emphasize that scientists have this under control and all is evidence-based, as opposed to media scare tactics and the gullible public's response.

Of course, given today's manufacturing processes and donor screening tests, plasma derivatives have an excellent safety record. Except for the times they didn't, as with Rh immune globulin (RhIg).

RhIg

The plasma derivative RhIg is instructive. RhIg is one of medicine's biggest success stories. It's produced from the plasma of donors who have a strong anti-D and its purpose is to prevent production of anti-D in Rh negative women who deliver Rh positive infants.

RhIg is a relatively safe blood derivative and products made in NA have never transmitted infections.

However, in the 1970s in Ireland and the former East Germany, several 100 women were infected with hepatitis C by batches of contaminated intravenous RhIg before donors were screened for the antibody to hepatitis C virus (HCV). That's because at the time we didn't know that HCV existed. [But there was a type of hepatitis called non-A, non-B hepatitis (NANBH). Only in 1989 was NANBH found to be caused by hepatitis C virus.]

Also, in 1994 in Ireland HCV RNA was detected in intravenous RhIg batches manufactured since 1991; a single donor was implicated and 19 women were found to have the same HCV strain as the donor. Sources:

RhIg for IM injection only' is manufactured from human plasma pools and can potentially transmit infectious agents such as viruses and prion diseases (e.g., vCJD). However, donor screening, donor testing and manufacturing processes significantly reduce these risks. Today we consider RhIg and other plasma derivatives to be safe for several reasons.

RhIg for IM use is prepared by Cohn cold ethanol fractionation, which includes heat(60C for 10 hours), low pH treatment, and a solvent detergent step that inactivates lipid-enveloped viruses such as hepatitis B, hepatitis C, and HIV. The process also uses a nanofilter that physically removes viruses, including non-lipid enveloped viruses such as hepatitis A and parvovirus B19.

The combination of inactivation and filtration greatly reduces viral load but does not entirely eliminate all viruses, some of which may be unknown.

'RhIg for IM or IV injection' is manufactured from human plasma pools using an anion-exchange column chromatography method. The resulting product contains almost no contaminating non-IgG protein. Like the IM-only products, manufacturing includes a virus nanofilter that removes lipid-enveloped and non-enveloped viruses based on size and solvent/detergent treatment that inactivates lipid-enveloped viruses.

Sounds great, right?

Except in the case of blood donors, we can only try to prevent transmission of infectious diseases in cellular products (red cells and platelets) or plasma derivatives if

We are aware of the emerging transfusion-associated disease (For hepatitis C, there was only the fuzzy, 'non-A, non-B' for the longest time.)

We know key risk factors so as to develop useful predonation screening questions (Non-A, non-B hepatitis had probably the same risks as hepatitis B or HIV, so experts believed the issue was at least partly covered by existing questions.)

A screening test exists for the putative organism (Not until tens of 1000s of transfusion recipients were infected worldwide)

The test has good sensitivity and specificity, i.e., can detect true positives and negatives, respectively, with reasonable accuracy. Implementing a new test is costly. Moreover, we cannot afford to reject donors needlessly.

In Canada, unlike the USA, blood experts decided that the initial 'non-A, non-B' (hepatitis C) surrogate tests lacked proper sensitivity and sensitivity (and tests were costly to implement). As a result, perhaps as many as 10,000 Canadians were infected. Victims were compensated, at least financially. Also see compensation packages.

PAID DONORS
We know from earlier tainted blood scandals that paid blood donors (often those who donate because they need money, e.g., young, sexually active donors and the poor) carry more risks for infectious diseases than volunteers.

Those pimping for paid donors say today's plasma derivatives, mainly sourced from paid donors, have a good safety record - and they do. But this assumes that screening questions and tests and manufacturing processes are 100% protective or close to it. And they are pretty good for the transfusion-transmitted diseases we know about.

PATIENT ADVOCACY GROUPS

Advocacy groups represent patients whose lives depend on blood components and derivatives. To them, the issue of paid vs volunteer donors seems of minor concern so long as the products they need are available and safe. And the 'powers that be' assure them that the products are safe AND Canada needs paid donors to insure availability.

SUMMARY

We await the results of Health Canada's round table discussions on April 10, 2013 that were closed to the media. Given the CBS position and that of patient advocacy groups, can there be any doubt that paid plasma donors are not only the future but are absolutely the savior for patients needing plasma derivatives? Who knew?

CBS has already made it know that closing a Canadian plasma collection centre and importing plasma derivatives from the USA is more cost effective. Actually, they didn't say that. They dissembled with crapola about how demand was down for plasma, omitting the reality that demand is up, BIG TIME, for plasma derivatives, and it was more cost-effective to buy from the USA instead of operating a Canadian facility.

As to emerging infectious diseases, we won't concern ourselves with them. They do not fit the current orthodoxy being preached by our gurus that blood has never been safer. Oh, and there is no evidence whatsoever that paid donors present a safety risk. You see, we have all these near perfect tests now....

As to the ethics of selling blood, that's not on anyone's agenda, certainly not CBS or Health Canada's closed-to-the-media round table. It's all about the money, folks. But the cover story is selling a story about safety.

We are the world, we are the children.We are the ones who make a brighter daySo let's start giving.There's a choice we're making.We're saving our own lives.It's true we'll make a better dayJust you and me.

3 comments:

As usual Pat I so enjoy your views, not just any views but views shaped by years of experience both in the field at the ground level, as an educator and as a believer in health and safety for the public good for our country.

I am so sad that this valuable view seems to be a voice in the wilderness - have we forgotten "Those who cannot learn from history are doomed to repeat it." George Santayana

No it will not be the same risk, but there will always be a risk - the Titanic was unsinkable. Infectious disease were beaten by antibiotics, etc etc. When so many lives and social fabric of this country are at stake, is it worth taking the risk? Is it all about money? - who after all is paying the bill. It is not CBS, it is our tax dollars that are going to buy the products made from this plasma to help those in need, we are paying for private companies to make a profit from our tax dollars - taking it out of our health care system (which is paying an organizations like CBS to do this not for profit).

But I guess we shouldn't worry, they will soon contract that out and with globalization, they will be able to buy cheaper plasma from developing countries - maybe they don't have to pay $20/donor, maybe they can also save money on testing and screening.

As a Hemophiliac 'still living' with the aftermath/debacle of the 80's blood tragedy, I'm amazed at the level of commercialization we're willing to impart on the "Human Condition". It would appear there is absolutely nothing we can't turn a profit on, so clever.

I have some issues with this.

Firstly, although all the noise has focused on the perceived safety of "paid for donation models", putting on my ambivalent corporate cash hat, no one seems to be saying anything about the costs of living with "not yet dead" infected/affected individuals.

Because of HIV and HEPC the Tax payers of Canada, not just the actual people responsible, were forced to contribute to a Billion dollar fund just to "compensate" Hemophiliacs and their families for their misfortune and inevitable early mortality.

This "Compensation", what the business world would more aptly describe as "Risk Management", was and still is being paid out based on the failure of the very things currently said will ensure the safety of the newly proposed Paid for Donation Model. Those being, Science, Integrity and the concern for our fellow man, although profit and remuneration wasn't blatantly part of the original 80's based problem as it is in 2013 I'm sure that won't add any extra variables to the equation. That's because "profit", whether obvious or obscured, will always be the down fall of any well derived plan for public health systems.

The moment you introduce "profit" to any system you also introduce the "how do I get some of that pie" mentality. Human beings are, by their very nature, competitively creative and resourceful. This is why we're still on this planet. The "haves" will always want more and the "have nots" will always look for a way to join the "haves".

The current Canadian system, by leaving the act of giving to be that of a more altruistic intent, removes the incentive to lie on the form or drag yourself to the donation clinic when you're really not feeling well. If you allow profit to enter into this then you introduce a strong incentive to "get out of bed and go to work".

The fact that we obtain blood products from abroad and those products may be obtained in a paid for donation model is irrelevant. As Canadians we have always been a sovereign nation with our own ideals and laws. Some of those ideals are in fact envied all over the globe. Just because another country does this does not mean we have to as well!

Because we need to purchase product from these very systems should be the 'incentive' to find a way out of this dependence. Necessity has and will always be the mother of invention and with every invention there were always rules during its development and I would say that we should maintain our "no pay" rule for this one. If not for ourselves then perhaps for our children.

We're a much brighter bunch than this current endeavor.

Lastly, the executive of the Hemophilia Society, claiming that "WE" see no risk is in fact misrepresenting the "WE" in the society. There are only a few of us left in the country since the 80's. We've watched as men of strong character and impressive resolve have made their lives, families and personal suffering very public so that those of us in the back would not disappear into the blackness of a silent eternity. The Executive, hemophiliac surprisingly, continually speaks with absolute confidence in the current science and altruistic values of the corporations applying for license. He continues to approach the science with little or no healthy cautiousness.

I on the other hand, as a career technical person, firmly believe that 'When' someone designs a more sensitive machine we 'WILL' find something else. My only hope is that 'We' find it before' IT' finds us.